Safety of Intravenous Thrombolysis for Wake-up Stroke

• Status: Completed
• Trial end date: 2014-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose is to demonstrate the safety of intravenous tissue plasminogen activator (IV t-PA) in ischemic stroke patients who present to the emergency department (ED) after awakening with the symptoms of suspected ischemic stroke.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Texas Health Science Center, Houston
• Collaborator: Genentech, Inc.
• Treatments: Plasminogen; Tissue Plasminogen Activator

Criteria

Inclusion Criteria:

• Suspected acute ischemic stroke that occurred during sleep or patients who wake up with focal neurological symptoms. This includes all patients who were last known to be neurologically normal the night before,but then found upon awakening with stroke deficits. It will be considered that the last known onset time is the time when the patient was last known to be well.

• 18 to 80 years old

• NIHSS (National Institutes of Health Stroke Scale) ≤25

• Blood Pressure ≤185 mmHg systolic & ≤110 mmHg diastolic at the time of enrollment.

Treatment of higher systolic BP is permitted, prior to enrollment

• IV t-PA must be given within 3 hours of awakening from sleep

• Female patients of child-bearing potential must have a negative pregnancy test prior to enrollment

Exclusion Criteria:

• CT Exclusion Criteria: Hypodensity >1/3 middle cerebral artery (MCA) territory on non-contrast cranial CT scan or evidence of intracranial or subarachnoid hemorrhage

• Prior ischemic stroke within 3 months of the presenting event

• History of intracranial hemorrhage

• Known secured or unsecured cerebral aneurysm or vascular malformation

• Inability to control systolic BP > 185 mmHg or diastolic BP > 110 mmHg with IV anti-hypertensive medications

• Known coagulopathy or evidence of active bleeding

• Surgical procedures, biopsy, subclavian venous or arterial puncture, trauma within 14 days of the event

• Gastrointestinal or genitourinary bleeding within 14 days of the event

• Treated with IV heparin within the previous 24 hours & an abnormal (partial thromboplastin time) PTT

• Oral anticoagulants & an (international normalized ratio) INR >1.7

• Platelet count <100,000

• Venous glucose either <50 or >450

• Any patient who qualifies for this protocol should not be treated with (intra-arterial therapy) IAT If the treating physician believes a patient should undergo IAT, those patients should be identified a priori and not enrolled into this protocol